Coronary Flow Reserve (CFR) in Cardiovascular Risk Stratification

Not Applicable

Completed

• Conditions: Ischemic Heart Disease; Ischemia, Myocardial
• Interventions: Diagnostic Test: CZT SPECT acquisition

• Registration Number: NCT03586492
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief Summary

CFR has been studied for few years using 82 Rubidium PET (positron emission tomography) /CT. CFR has shown to be correlated with cardiovascular events occurring in the 10 following years. CFR also helps to identify multivessel coronary disease. Few studies have shown the possibility to calculate CFR during myocardial perfusion SPECT on new ultrafast CZT cameras.

Detailed Description

Evaluate the contribution of CZT SPECT CFR in cardiovascular risk stratification: correlation with clinical scores, with calcium score, and when pathological with coronarography findings especially fractional flow reserve (FFR).

Study Timeline

• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-13
• Study Start: 2018-11-05
• Primary Completion: 2020-11-05
• Study Completion: 2020-11-05
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Patients referred for myocardial ischemia screening

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Exclusion Criteria

• Patient already suffering from coronary disease with angioplasty, bypass surgery or myocardial infarction.
• Contraindications related to the stress test:

Acute Coronary Syndrome <5 days Unstable angina Stenosis of left main artery untreated Uncontrolled severe rhythm disorders Uncontrolled heart failure

• Contraindications to dipyridamole and regadenoson:

Hypotension (systolic <90mmHg) Severe pulmonary arterial hypertension Bradycardia <40 beats / minute Sinusal Dysfunction and 2nd or 3rd degree Atrioventricular block Decompensated Heart Failure with Ejection Fraction <25% Stenosis of supra-aortic trunks unilateral> 70% or bilateral> 50% Dipyridamole and regadenoson allergy

• Patients with pacemaker, or who have had valvular surgery,
• Well-known dilated cardiopathy
• Pregnant or breastfeeding women,
• Minor people
• Persons under guardianship or under guardianship

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with myocardial ischemia	CZT SPECT acquisition	-

Primary Outcome Measures

Name	Time	Method
Regional and global CFR	Day 0	Regional and global CFR calculated from CZT SPECT myocardial perfusion: correlation with clinical score and calcium score

Secondary Outcome Measures

Name	Time	Method
FFR Regional CFR after one year of medical treatment	Up to one year	FFR measured during coronarography if there is an intermediate stenosis Regional CFR if there is an intermediate coronary stenosis with medical treatment, after one year of treatment, calculated during a new SPECT CZT exam

Trial Locations

Locations (2)

CHRU de Tours; 🇫🇷 Tours, France

CHR d'Orleans; 🇫🇷 Orléans, France